Open-label Brexpiprazole fMRI Trial in Adults With Major Depressive Disorder and Anxiety
Primary Purpose
Major Depressive Disorder (MDD)
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Brexpiprazole
Sponsored by
About this trial
This is an interventional basic science trial for Major Depressive Disorder (MDD) focused on measuring Major depressive disorder (MDD), symptoms of anxiety, fMRI, brain networks, modularity, community structure, brexpiprazole, default mode network, salience network, central executive network, functional brain connectivity
Eligibility Criteria
Inclusion Criteria:
- 18 to 65 year of age
- Major Depressive Disorder (MDD) with symptoms of anxiety
- Stable treatment with less than 50% improvement
Exclusion Criteria:
- Contraindicated to perform fMRI scan
- Previous exposure to brexpiprazole
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1
Arm Description
Brexpiprazole
Outcomes
Primary Outcome Measures
Change in fMRI resting-state salience network community structure from baseline to post-treatment
Secondary Outcome Measures
Association between change in resting-state salience network community structure and change in MADRS total score from baseline to post treatment.
Utilizing Jaccardized Czekanowski index
Change in Default Mode Network (DMN) community structure during emotional face viewing from baseline to post-treatment.
Utilizing Jaccardized Czekanowski index
Change in Central Executive Network (CEN) community structure during a working memory task from baseline to post-treatment.
Utilizing Jaccardized Czekanowski index
Full Information
NCT ID
NCT05504486
First Posted
May 31, 2022
Last Updated
January 26, 2023
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
H. Lundbeck A/S
1. Study Identification
Unique Protocol Identification Number
NCT05504486
Brief Title
Open-label Brexpiprazole fMRI Trial in Adults With Major Depressive Disorder and Anxiety
Official Title
A Phase 4, Multicenter, Single-arm, Open-label, Interventional fMRI Trial to Assess the Effect of Brexpiprazole as Adjunctive Therapy on Functional Brain Network Organization in Adults With Major Depressive Disorder and Symptoms of Anxiety
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor strategic decision
Study Start Date
August 29, 2022 (Anticipated)
Primary Completion Date
March 22, 2023 (Anticipated)
Study Completion Date
April 5, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
H. Lundbeck A/S
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to use fMRI to evaluate the effects of brexpiprazole as add-on therapy to antidepressants on brain connectivity in individuals with MDD and symptoms of anxiety, aged 18 to 65.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder (MDD)
Keywords
Major depressive disorder (MDD), symptoms of anxiety, fMRI, brain networks, modularity, community structure, brexpiprazole, default mode network, salience network, central executive network, functional brain connectivity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Brexpiprazole
Intervention Type
Drug
Intervention Name(s)
Brexpiprazole
Intervention Description
Oral tablet; take once daily; target daily dose of 2 mg
Primary Outcome Measure Information:
Title
Change in fMRI resting-state salience network community structure from baseline to post-treatment
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
Association between change in resting-state salience network community structure and change in MADRS total score from baseline to post treatment.
Description
Utilizing Jaccardized Czekanowski index
Time Frame
Week 6
Title
Change in Default Mode Network (DMN) community structure during emotional face viewing from baseline to post-treatment.
Description
Utilizing Jaccardized Czekanowski index
Time Frame
Week 6
Title
Change in Central Executive Network (CEN) community structure during a working memory task from baseline to post-treatment.
Description
Utilizing Jaccardized Czekanowski index
Time Frame
Week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 to 65 year of age
Major Depressive Disorder (MDD) with symptoms of anxiety
Stable treatment with less than 50% improvement
Exclusion Criteria:
Contraindicated to perform fMRI scan
Previous exposure to brexpiprazole
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Open-label Brexpiprazole fMRI Trial in Adults With Major Depressive Disorder and Anxiety
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